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Research Program Coordinator
Full/Part Time: Full Time
Department: 031 - Hematology/Oncology
Requisition Number: 14-1645110
The Research Program Coordinator contributes to the advancement of research both scientifically and operationally. Under direct faculty supervision within the Division of Immunotherapy, Icahn School of Medicine at Mount Sinai Department, candidate will coordinate research projects that are part of the Immunotherapy Program. The Research Program Coordinator contributes to the advancement of research both scientifically and operationally. This position will assist faculty in the development of evaluation tools and methods associated with clinical trials. Coordinates research projects, including meetings, timelines, and deliverable, assist with Institutional Review Board clinical trial protocols, the design of data collection tools, data analysis and in manuscript preparation and presentations.
Duties and Responsibilities:
Coordinates with the Clinical Research Manager on creating budgets for one-year, multi-year, and multi-site budgets for grants. Prepares internal routing forms for grant submission. Assists with subcontract consortium agreements, within and across institutions.
Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.
Secures, delivers and ships clinical specimens as required by the protocol.
Develops and maintains research databases. Performs primary data collection for clinical studies, including analysis of administrative databases, analysis of electronic medical records, and analysis of electronic clinical data sources.
Interfaces and communicates regularly with Principal Investigator (PI) and study staff to assist with development of IND/IDE applications, including the clinical protocol, and to provide progress reports. Coordinates, prepares and assembles all regulatory documents in the preparation for audits, including internal, cooperative groups or FDA, and/or monitoring visits.
Performs primary data entry into research database. Analyzes research data, including performing basic tests for statistical significance, as well as developing graphical and tabular presentations of the results. Assists in writing scientific abstracts, manuscripts and journal publications.
Performs other related duties.
The successful candidate must possess a Master's degree, Requires 5 years of experience in regulatory affairs with at least 3 years experience submitting and maintaining IND applications to the FDA. Experience with government and non-government funded agencies to help coordinate and assist with grant proposals, IRB submissions.
In-depth knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents and the conduct of a research protocol.
Knowledge of policies, procedures and SOPs specifically related to regulatory documents. Experience with IND applications and maintenance.
Excellent oral and written communication.
Ability to manage timelines and deadlines for multiple projects.
Strong organizational, time management, decision-making, and analytical thinking/problem-solving skills.
Demonstrated ability to work independently and toward project milestones.
Ability to interact on a scientific level with medical staff, physicians, and representatives of national and pharmaceutical groups.
Ability to collaboratively assure protocol compliance and completion.
Familiarity with research methodologies.
Skill and Abilities
Good organization skills, time management skills, excellent writing skills and the ability to manage several concurrent tasks.
Computer proficiency in Word, Excel, Access, statistical software programs such as SAS or SPSS, and decision analysis software such as DATA Pro, Medidata Rave, eRAP, REDCap is highly desirable. Must have sufficient familiarity and experience with presentation software such as Microsoft PowerPoint.
Ability to independently perform medical literature reviews and library searches.
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.